510(k) Report

510(k) · Cleared

Recalled · 2009

Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33

K003277510(k) TraditionalCleared Dec 21, 200063-day reviewClass II21 CFR 878.4750Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Powermed, Inc. · GDW Staple, Implantable

Cleared on Dec 21, 2000 after a 63-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 70 later devices descend from it. It has been recalled 3 times.

Decided
Dec 21, 2000
Review
63 days
Class
Class II
Product code
GDW
Recalls
3
Predicates
0

70 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2007: 4 descendants cleared2002: 5 descendants cleared2004: 3 descendants cleared2001: 1 descendant cleared2003: 2 descendants cleared2006: 4 descendants cleared2005: 2 descendants cleared2010: 3 descendants cleared2008: 2 descendants cleared2011: 1 descendant cleared2009: 2 descendants cleared2019: 2 descendants cleared2015: 3 descendants cleared2018: 4 descendants cleared2017: 5 descendants cleared2014: 4 descendants cleared2012: 4 descendants cleared2016: 6 descendants cleared2021: 2 descendants cleared2023: 3 descendants cleared2020: 2 descendants cleared2013: 1 descendant cleared2026: 3 descendants cleared2025: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK003277 Surgassist System with Circular Stapler Disposable Loading Unit…Powermed, Inc. · 2000
  2. Descendant · cites it directly · 66 of its ownK012809 Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001
  3. Descendant · 2 generations on · 47 of its ownK020719 Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM…Power Medical Interventions, Inc. · 2002 · Recalled
  4. Descendant · 3 generations on · 46 of its ownK030653 Surgassist Straight Linear Stapler and Straight Linear 4 Row NO…Power Medical Interventions, Inc. · 2003
  5. Descendant · 4 generations on · 45 of its ownK040398 Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004
  6. Descendant · 3 generations on · 25 of its ownK040720 Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30…Power Medical Interventions, Inc. · 2004 · Recalled

Showing 5 of 70 descendants. See all descendants

Descendants cleared per year

2001: 12002: 52003: 22004: 32005: 22006: 42007: 42008: 22009: 22010: 32011: 12012: 42013: 12014: 42015: 32016: 62017: 52018: 42019: 22020: 22021: 22022: 12023: 32025: 12026: 3
2001high 6 (2016) · low 0 (2024)2026

Most influential descendants

Showing 5 of 70 · See all
  • K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc. · 2001 · cites it directly66descendants
  • K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with Blue and…Power Medical Interventions, Inc. · 2002 · 2 generations on47descendants
  • K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital Loading…Power Medical Interventions, Inc. · 2003 · 3 generations on46descendants
  • K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc. · 2004 · 4 generations on45descendants
  • K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55 MM, 75 MMPower Medical Interventions, Inc. · 2004 · 3 generations on25descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003277Surgassist System with Circular Stapler Disposable Loading Unit, Model…Powermed, Inc.2000—
+1K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc.2001—
+2K020719Surgassist System Straight Linear Cutter Digital Loading Unit, 55MM, 30MM with…Power Medical Interventions, Inc.20021
+3K030653Surgassist Straight Linear Stapler and Straight Linear 4 Row NO Knife Digital…Power Medical Interventions, Inc.2003—
+4K040398Surgassist Straight Linear 4 Row NO Knife Dlus with ReloadsPower Medical Interventions, Inc.2004—
+3K040720Surgassist Computer Mediated Linear Cutter Digital Loading Units, 30 MM, 55…Power Medical Interventions, Inc.20041

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200250
200320
200430
200520
200640
200740
200820
200920
201030
201110
201240
201310
201440
201530
201660
201750
201840
201920
202020
202120
202210
202330
202510
202630
FIG. 1 — Lineage of K003277, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GDW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GDW device

  1. #1 K253657 Tri-staple 2.0™ Reloads; Endo GIA™ Reloads…score 15.0 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (70)

See all 70

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012809Surgassist Right Angle Linear Cutter Dlu - 45MM, Model RALC45Power Medical Interventions, Inc.200166
K021249Surgassist Flexshaft 2, Model FS2 14Power Medical Interventions, Inc.200222
K071708I45, I45S, I60, and I60SPower Medical Interventions, Inc.200721
K020343Surgassist System; Wireless Remote Control (Component); Wired Remote ControlPower Medical Interventions, Inc.200213
K032701Surgassist Circular Stapler Digital Loading Units (CS21, CS25, CS29, CS33)Power Medical Interventions, Inc.20031
K061649Power Circular Stapler Digital Loading Unit with and Without SheathPower Medical Interventions, Inc.20060
K040024Surgassist Circular Stapler Digital Loading Units - 29 MM, Model CS29Power Medical Interventions, Inc.20040

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 23, 2009Not classifiedZ-0392-2010Nonconforming Material/ComponentLack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical…
Jun 30, 2003Not classifiedZ-1049-03Otherlatching mechanism failure
Jun 30, 2003Not classifiedZ-1048-03Otherlatching mechanism failure

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K012809 (Power Medical Interventions, Inc., 2001) has gone furthest, with 66 descendants of its own.

How does its category compare?

All GDW devices

GDW Staple, Implantable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GDW

3in 2025

2007: 82008: 72009: 132010: 102011: 112012: 92013: 132014: 152015: 82016: 112017: 132018: 72019: 122020: 102021: 92022: 72023: 42024: 22025: 32026 (partial year): 3
2007high 15 (2014) · low 2 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GDW

111in 2025

2007: 56 days median2008: 57 days median2009: 27 days median2010: 39 days median2011: 49 days median2012: 45 days median2013: 49 days median2014: 63 days median2015: 111 days median2016: 96 days median2017: 103 days median2018: 90 days median2019: 205 days median2020: 88 days median2021: 233 days median2022: 89 days median2023: 267 days median2025: 111 days median2026 (partial year): 141 days median
2007high 267 (2023) · low 27 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GDW

3in 2025

2007: 92009: 222010: 22011: 92012: 11, 1 Class I2013: 12015: 62016: 22017: 32018: 32019: 4, 4 Class I2020: 112023: 12025: 3
2007high 22 (2009) · low 0 (2008)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · GDW

11,905in 2025

2007: 2,4012008: 2,3802009: 4,0142010: 3,7682011: 3,8262012: 3,7172013: 3,7772014: 4,7842015: 4,8992016: 5,1062017: 11,6432018: 14,9142019: 16,6002020: 12,3322021: 13,0152022: 13,6052023: 14,6232024: 13,2802025: 11,905
2007high 16,600 (2019) · low 2,380 (2008)2025

MAUDE reports naming product code GDW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200785692,401
200875702,380
20091327224,014
2010103923,768
2011114993,826
201294511 (1)3,717
2013134913,777
2014156304,784
2015811164,899
2016119625,106
201713103311,643
2018790314,914
2019122054 (4)16,600
202010881112,332
20219233013,015
2022789013,605
20234267114,623
20242—013,280
20253111311,905
202631410—

Recent decisions in GDW

The GDW category page

  • K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic…Ezisurg Medical Co., Ltd. · 2026
  • K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler…Ethicon Endo-Surgery, LLC · 2026
  • K253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads…Covidien (Part of Medtronic) · 2026
  • K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000…Ethicon Endo-Surgery, LLC · 2025
  • K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm…Ethicon Endo-Surgery, LLC · 2025

https://510kreport.com/device/K003277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003277: Surgassist System with Circular Stapler Disposable Loading Unit, Model CS21,CS25,CS29,CS33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003277

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026